[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07717385":3,"trial-entities:NCT07717385":128,"trial-summary:NCT07717385":136},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":24,"study_type":36,"primary_purpose":37,"phases":38,"enrollment_info":40,"interventions":43,"primary_outcomes":51,"secondary_outcomes":59,"sex":76,"minimum_age":77,"maximum_age":78,"healthy_volunteers":79,"eligibility_criteria":80,"std_ages":99,"locations":102,"central_contacts":121,"overall_officials":124,"references":126,"see_also_links":127},"NCT07717385","EFF-NM-90D-2026-01","Sleep More, Stress Less: 90-Day Trial of Neuralli Mood","Effects of Neuralli Mood Probiotic Supplementation on Stress, Sleep Disturbance, Mood, and Burnout: A 90-Day Single-Arm Study","RECRUITING","2027-09-28","2026-07","2026-07-21","2026-06-30","Efforia, Inc","INDUSTRY",false,"This decentralized, single-arm study evaluates the effects of 90 days of daily Neuralli Mood supplementation on perceived stress, sleep disturbance, mood, anxiety, depressive symptoms, happiness, and occupational burnout in adults experiencing stress or occasional sleep disruption. Participants serve as their own controls, completing validated self-report measures before beginning supplementation and again after the 90-day intervention, with safety and adherence check-ins during the study.","Neuralli Mood is a probiotic and postbiotic dietary supplement containing the proprietary gut-brain strains L. plantarum PS128 and heat-treated L. paracasei PS23. Participants take two capsules once daily, with or without food, at a consistent time for 90 days. Each two-capsule daily dose contains 30 billion CFU of L. plantarum PS128 and 20 billion heat-treated cells of L. paracasei PS23.\n\nThe study uses a prospective, open-label, single-group, within-participant design. Participants complete baseline assessments before the first dose and repeat the primary and secondary outcome assessments at the end of the 90-day supplementation period. Scheduled check-ins are used to assess adherence, tolerability, and adverse events.\n\nThe study is exploratory and is intended to generate preliminary evidence and individualized before-and-after information. Results will be interpreted in light of the absence of a concurrent control group, participant self-selection, expectation effects, and reliance on self-reported outcomes.",[19,20,21,22,23],"Psychological Stress","Sleep Disturbance","Anxiety Symptoms","Depressive Symptoms","Occupational Burnout",[25,26,27,28,29,30,31,32,33,34,35],"Neuralli Mood","Probiotic","Postbiotic","Psychobiotic","Gut-brain axis","Lactiplantibacillus plantarum PS128","Lacticaseibacillus paracasei PS23","Stress","Sleep","Burnout","Citizen science","INTERVENTIONAL","OTHER",[39],"NA",{"count":41,"type":42},100,"ESTIMATED",[44],{"type":45,"name":25,"description":46,"armGroupLabels":47,"otherNames":49},"DIETARY_SUPPLEMENT","Two acid-resistant capsules taken once daily for 90 days. Each daily dose contains 30 billion CFU of L. plantarum PS128 and 20 billion heat-treated cells of L. paracasei PS23. Other ingredients include microcrystalline cellulose, hypromellose, pectin, glycerol, silica, and magnesium stearate.",[48],"Neuralli Mood Supplementation",[50],"Bened Life Neuralli Mood",[52,56],{"measure":53,"description":54,"timeFrame":55},"Change in Depression Anxiety and Stress Scales-21 Stress Subscale Score","Change from baseline in the Stress subscale score of the Depression Anxiety and Stress Scales-21. Higher scores (maximum score of 42) represent greater severity of stress symptoms. (Minimum score of 0).","Baseline before the first dose and end of the 90-day supplementation period",{"measure":57,"description":58,"timeFrame":55},"Change in PROMIS Sleep Disturbance Score","Change from baseline in the PROMIS Sleep Disturbance score. Higher scores (Maximum 40) represent greater sleep disturbance. Lower (Minimum 8) represent lower sleep disturbance.",[60,63,66,69,72],{"measure":61,"description":62,"timeFrame":55},"Change in Depression Anxiety and Stress Scales-21 Anxiety Subscale Score","Change from baseline in the Anxiety subscale score of the Depression Anxiety and Stress Scales-21. Higher scores represent greater severity of anxiety symptoms. (minimum 0 to maximum 21)",{"measure":64,"description":65,"timeFrame":55},"Change in Depression Anxiety and Stress Scales-21 Depression Subscale Score","Change from baseline in the Depression subscale score of the Depression Anxiety and Stress Scales-21. Higher scores represent greater severity of depressive symptoms. (Minumum 0, maximum 21)",{"measure":67,"description":68,"timeFrame":55},"Change in Oxford Happiness Questionnaire Score","Change from baseline in the Oxford Happiness Questionnaire total score. Higher raw scores (max 174) represent greater self-reported happiness versus low scores (min 29).",{"measure":70,"description":71,"timeFrame":55},"Change in Burnout Assessment Survey Score","Change from baseline in the total score from the study's Burnout Assessment Survey, interpreted according to the instrument's scoring procedures. Raw Sum Minimum Score: 23 (Patient responds \"Never\" to every single item)Raw Sum Maximum Score: 115 (Patient responds \"Always\" to every single item)",{"measure":73,"description":74,"timeFrame":75},"Number of Participants With Treatment-Emergent Adverse Events","Number and proportion of participants reporting adverse events during supplementation, including gastrointestinal symptoms, allergic reactions, mood changes, sleep-related symptoms, discontinuations, and events requiring medical attention.","From the first dose through completion of the 90-day supplementation period","ALL","18 Years",null,true,{"inclusion":81,"exclusion":87,"raw_text":98},[82,83,84,85,86],"Age 18 years or older and able to provide informed consent.","Generally healthy adult experiencing stress, occasional sleep disruption, low mood, anxiety symptoms, or work-related burnout.","Willing and able to take two capsules of Neuralli Mood daily for 90 days.","Willing and able to complete electronic baseline, follow-up, adherence, and safety assessments.","Has reliable access to the internet and an email-enabled device.",[88,89,90,91,92,93,94,95,96,97],"Pregnant or nursing.","Known allergy or hypersensitivity to Neuralli Mood, probiotics, or any product ingredient.","Severe or unstable gastrointestinal disease, including a condition for which probiotic use may be inappropriate.","Immunocompromised status or current immunosuppressive therapy.","Severe or unstable mood disorder, acute psychiatric symptoms, or a current risk of harm to self or others.","A clinically significant sleep disorder for which participation or changes in symptoms should be managed by a healthcare professional.","Cognitive impairment or another condition that prevents informed consent or reliable completion of study procedures.","History of a severe allergic reaction when the investigator determines probiotic use may present an unacceptable risk.","Use of a medication or presence of a medical condition for which a healthcare professional advises against probiotic supplementation.","Any other circumstance that, in the investigator's judgment, makes participation inappropriate or unsafe.","Inclusion Criteria:\n\n* Age 18 years or older and able to provide informed consent.\n* Generally healthy adult experiencing stress, occasional sleep disruption, low mood, anxiety symptoms, or work-related burnout.\n* Willing and able to take two capsules of Neuralli Mood daily for 90 days.\n* Willing and able to complete electronic baseline, follow-up, adherence, and safety assessments.\n* Has reliable access to the internet and an email-enabled device.\n\nExclusion Criteria:\n\n* Pregnant or nursing.\n* Known allergy or hypersensitivity to Neuralli Mood, probiotics, or any product ingredient.\n* Severe or unstable gastrointestinal disease, including a condition for which probiotic use may be inappropriate.\n* Immunocompromised status or current immunosuppressive therapy.\n* Severe or unstable mood disorder, acute psychiatric symptoms, or a current risk of harm to self or others.\n* A clinically significant sleep disorder for which participation or changes in symptoms should be managed by a healthcare professional.\n* Cognitive impairment or another condition that prevents informed consent or reliable completion of study procedures.\n* History of a severe allergic reaction when the investigator determines probiotic use may present an unacceptable risk.\n* Use of a medication or presence of a medical condition for which a healthcare professional advises against probiotic supplementation.\n* Any other circumstance that, in the investigator's judgment, makes participation inappropriate or unsafe.",[100,101],"ADULT","OLDER_ADULT",[103],{"facility":104,"status":8,"city":105,"state":105,"zip":106,"country":107,"contacts":108,"geoPoint":118},"Efforia - Decentralized United States Study","New York","10003","United States",[109,113,115],{"name":110,"role":111,"email":112},"Matthew Amsden","CONTACT","help@efforia.com",{"name":110,"role":114},"PRINCIPAL_INVESTIGATOR",{"name":116,"role":117},"Viral Patel","SUB_INVESTIGATOR",{"lat":119,"lon":120},40.71427,-74.00597,[122],{"name":110,"role":111,"phone":123,"email":112},"+13232844626",[125],{"name":110,"affiliation":13,"role":114},[],[],{"nct_id":4,"conditions":129,"biomarkers":135},[130,131,132,133,134],"Anxiety","Burnout, Professional","Depression","Psychological stress","Sleep Disorder",[],{"nct_id":4,"found":79,"summary":137,"prompt_version":147},{"design":138,"status":139,"heading":140,"summary":141,"follow_up":142,"word_count":143,"commitments":144,"compensation":145,"drugs_mentioned":146},"This is a single-arm study, meaning all participants will receive the Neuralli Mood supplement. It is an open-label study, so both you and the researchers will know you are taking the supplement.","completed","Neuralli Mood for Stress and Sleep","This study is testing a dietary supplement called Neuralli Mood to see if it can help adults who are experiencing stress, occasional sleep problems, low mood, anxiety, or work-related burnout. Neuralli Mood contains two specific probiotic strains, L. plantarum PS128 and L. paracasei PS23. You could join if you are an adult (18 or older) and generally healthy but experiencing these issues. The study will look at changes in your stress levels and sleep quality after taking Neuralli Mood for 90 days. The current status of this study is unclear, and it plans to enroll 100 participants.","You will be assessed at the end of the 90-day supplementation period, which is when the primary outcomes are measured.",97,"You would take two capsules of Neuralli Mood once daily for 90 days. You will also complete electronic assessments at the beginning and end of the 90-day period, with check-ins for safety and adherence.","Not stated in the trial record.",[25],"v2"]